SOP on Operation of Bin Blender

1.0 Objective: To lay down a procedure for the operation of Bin Blender.2.0 Scope: This standard operating procedure Operation of Bin Blender is applicable to the Bin Blender located in the manufacturing area.3.0 Responsibility: Officer, Executive – Production Department follow procedure while executing the operationManager – Production Department for overall compliance 4.0 Procedure for Operation … Read more

SOP on Cleaning of Strip Pack Machine

1.0 OBJECTIVE: To lay down a procedure for cleaning of Strip Pack Machine.2.0 SCOPE: This procedure is applicable to the cleaning of strip pack machine in the3.0 RESPONSIBILITY: Operator, Officer, and Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE :4.1 TYPE A Cleaning of Strip Pack MachineChange over from one batch to the next … Read more

SOP for Index Type Rotary Bottle Washing Machine

1.0 Objective: To lay down the procedure for the operation and cleaning of the Index Type Rotary Bottle Washing Machine.2.0 Scope: This Standard Operating Procedure for Bottle Washing Machine is applicable for the operation and cleaning of the Index Type Rotary Bottle Washing Machine in the liquid Oral department.3.0 Responsibility:Production Executive, Production Officer. 4.0 Procedure:4.1 … Read more

SOP for Operation & Calibration of pH Meter

1.0 Objective: To lay down the procedure for the Operation & Calibration of pH meter2.0 Scope: This sop of ph meter shall be applicable to the Analytical Development Department in Pharmaceuticals3.0 Reference: In-House4.0 Responsibility: Executive/Officer- Analytical Development5.0 Accountability: Manager-Analytical Development. 6.0 Procedure for pH meter, Make Lab India.:6.1 Cleaning Procedure for pH Meter:6.1.1 Clean the … Read more

SOP for Operation and Calibration of Dissolution Apparatus (Tester)

1.0 Objective: 1.1 To lay down the procedure for the Operation and Calibration of Dissolution Apparatus (Tester).2.0 Scope: 2.1 This SOP shall be applicable to the Analytical development at Pharmaceutical Analytical Lab.3.0 References: 3.1 In-House SOP of dissolution apparatus 4.0 Responsibility:4.1 AD Executive/Sr. Executive.4.2 To follow the procedure for calibration as per SOP.3.3 To maintain … Read more

SOP for Operation and cleaning of Tunnel sterilizer

1.0 Purpose: To lay down the procedure for the operation and cleaning of tunnel sterilizer.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of depyrogenation tunnel installed in production.3.0 Responsibility:3.1 The line coordinators who are trained shall carry out the operation and cleaning process as per SOP.3.2 Officers/ sr. officers shall … Read more

SOP for Liquid tanks, Pipelines, and Filling machine

Blue SOP file for liquid tanks, pipelines, and filling machine placed on a stainless steel table inside a pharmaceutical production area, with stainless steel tanks and filling equipment visible in the background.

1.0 OBJECTIVE: To lay down the procedure for cleaning of Liquid tanks, Pipelines, and Filling machine. 2.0 SCOPE: This procedure is applicable for cleaning of Liquid tanks, Pipelines, and Filling machine in the liquid Oral department. 3.0 RESPONSIBILITY:Production Officer, Production Executive. 4.1 PROCEDURE: 4.1.1 Before starting the cleaning, check that the tank is empty and … Read more

SOP for Operation and Calibration of Analytical Balance

1.0 Objective: 1.1 To lay down the procedure for the Operation and Calibration of Analytical Balance (ISHIDA).2.0 Scope: 2.1 This SOP is applicable for the operation and calibration of Analytical Balance in Analytical Development labs.3.0 References: 3.1 In-house4.0 Responsibility:4.1 Executive/Officer Analytical Development Shall be responsible for the operation and calibration of the analytical balance.5.0 Accountability:5.1 … Read more

SOP on Pest & Rodent Control

1.0 Objective: To lay down the procedure for Pest & Rodent Control within the manufacturing areas.2.0 Scope: This pest & rodent control standard operating procedure within the manufacturing plant, factory areas and food industries.3.0 Responsibility: The housekeeping department officer/Executives is responsible for the implementation of this procedure.4.0 Accountability:QA Head shall be accountable for the implementation … Read more

SOP for Operation & Calibration of Water bath

1.0 OBJECTIVE: 1.1 To lay down the procedure for the operation & calibration of water bath2.0 SCOPE: 2.1 This SOP is applicable to Analytical development at Pharmaceutical Lab.3.0 RESPONSIBILITY3.1 Officer/Executive – Analytical Development3.2 Manager-AD for overall compliance with this procedure4.0 ACCOUNTABILITY4.1 Manager-AD 5.0 PROCEDURE 5.1 Operating procedure5.1.1 Ensure that the instrument is clean and within … Read more

SOP for Cleaning and Storage of Filling accessories

1.0 Purpose: To lay down the procedure for cleaning and storage of filling accessories.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and storage of filling accessories at the production department.3.0 Responsibility:3.1 Operator shall carry out the operation process.3.2 Officers shall be responsible to supervise the process.3.3 Head Production/ Designee shall be responsible … Read more

SOP on Receipt Materials Bill Realization and Deviation

1.0 Objective: 1.1 To describe the procedure for Bills Realization. 2.0 Scope: 2.1 This procedure applies to the Purchase department in Pharmaceuticals. 3.0 Responsibility: 3.1 Asst. Manager- Purchase 4.0 Accountability:4.1 General Manager – Purchase in coordination with respective Department Heads like QC and Stores. 5.0 Procedure for Bill Realization 5.1 The nature of deviations may … Read more

SOP for Operation and cleaning of lyophilizer

1.0 Purpose: To lay down the procedure for the operation and cleaning of lyophilizer.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of the Lyophilizer, located on the production floor.3.0 Responsibility:3.1 Officer Production3.2 Head Production 4.0 Safety considerations:4.1 Persons who are familiar with the basic safety and accident prevention regulations and … Read more

Sterilization of Piping System of blending Tanks

1.0 Purpose: To describe the procedure for auto-mode Sterilization of Piping System of blending Tanks.2.0 Aim: This Standard Operating Procedure is applicable to auto-mode Sterilization of Piping System of blending Tanks in solution preparation and formulation blending tanks. 3.0 Responsibility: 3.1 Officer/Executive line coordinator shall execute this SOP.3.2 Production Head/designee shall be responsible for implementation … Read more

SOP for Manual Visual inspection of filled vials

1.0 Purpose: To lay down the procedure for manual visual inspection of filled vials.2.0 Aim: This Standard Operating Procedure is applicable for packing vaccines at the packing section. 3.0 Responsibility:3.1 Trained operators for visual inspection activities of vials.3.2 Officer is responsible for checking the activity.3.3 IPQA shall be responsible for compliance as per this SOP.3.4 … Read more

SOP for Operation of Particle counter

1.0 Purpose: To lay down the procedure for the operation of the particle counter2.0 Aim: This Standard Operating Procedure is applicable to the operation on the Production floor. 3.0 Responsibility:3.1 Line coordinators shall execute the process.3.2 Officer / Sr. Officer shall check & control the activity.3.3 Production Head shall be responsible for the execution of … Read more